Carly Hom

Carly Hom is an experienced professional in quality assurance and regulatory affairs, currently serving as a Sr. Quality Assurance Manager at Cardiac Dimensions since July 2025. Previously, Carly held the position of Sr. Quality Systems Manager at MicroSurgical Technology, where responsibilities included acting as Management Representative and PRRC while ensuring supplier compliance with quality agreements. Carly also worked as a Sr. Regulatory Affairs Manager at Paige, leading the development of a significant FDA pre-submission package and an EU IVDR Transition Quality Plan. As an RA/QA Manager at EchoNous Inc., Carly successfully managed a 510(k) submission contributing to product clearance and initiated a comprehensive overhaul of the QMS for compliance with EU MDR. Earlier roles included serving as a Senior Regulatory & Quality Assurance Specialist at Cleerly, where Carly played a key role in securing 510(k) clearances for innovative devices using machine learning. Carly holds an MBA in Marketing and International Business from Arizona State University and has completed a Business Administration and Management program at Peking University.